NO321076B1 - Farmasoytisk preparat for oral administrasjon inneholdende cyklosporin - Google Patents
Farmasoytisk preparat for oral administrasjon inneholdende cyklosporin Download PDFInfo
- Publication number
- NO321076B1 NO321076B1 NO19954152A NO954152A NO321076B1 NO 321076 B1 NO321076 B1 NO 321076B1 NO 19954152 A NO19954152 A NO 19954152A NO 954152 A NO954152 A NO 954152A NO 321076 B1 NO321076 B1 NO 321076B1
- Authority
- NO
- Norway
- Prior art keywords
- pharmaceutical preparation
- preparation according
- cyclosporine
- peg
- component
- Prior art date
Links
- PMATZTZNYRCHOR-CGLBZJNRSA-N Cyclosporin A Chemical compound CC[C@@H]1NC(=O)[C@H]([C@H](O)[C@H](C)C\C=C\C)N(C)C(=O)[C@H](C(C)C)N(C)C(=O)[C@H](CC(C)C)N(C)C(=O)[C@H](CC(C)C)N(C)C(=O)[C@@H](C)NC(=O)[C@H](C)NC(=O)[C@H](CC(C)C)N(C)C(=O)[C@H](C(C)C)NC(=O)[C@H](CC(C)C)N(C)C(=O)CN(C)C1=O PMATZTZNYRCHOR-CGLBZJNRSA-N 0.000 title claims abstract description 22
- 108010036949 Cyclosporine Proteins 0.000 title claims abstract description 22
- 229930182912 cyclosporin Natural products 0.000 title claims abstract description 22
- 229960001265 ciclosporin Drugs 0.000 title claims abstract description 20
- 239000000825 pharmaceutical preparation Substances 0.000 title claims description 18
- 229930105110 Cyclosporin A Natural products 0.000 title claims description 3
- 239000000203 mixture Substances 0.000 claims abstract description 20
- RTZKZFJDLAIYFH-UHFFFAOYSA-N Diethyl ether Chemical compound CCOCC RTZKZFJDLAIYFH-UHFFFAOYSA-N 0.000 claims abstract description 8
- 229920005862 polyol Polymers 0.000 claims abstract description 5
- 235000015112 vegetable and seed oil Nutrition 0.000 claims abstract description 5
- 239000008158 vegetable oil Substances 0.000 claims abstract description 5
- LYCAIKOWRPUZTN-UHFFFAOYSA-N Ethylene glycol Chemical compound OCCO LYCAIKOWRPUZTN-UHFFFAOYSA-N 0.000 claims abstract description 4
- 239000004721 Polyphenylene oxide Substances 0.000 claims abstract description 4
- 125000002947 alkylene group Chemical group 0.000 claims abstract description 4
- 229920001515 polyalkylene glycol Polymers 0.000 claims abstract description 4
- 229920000570 polyether Polymers 0.000 claims abstract description 4
- 125000000217 alkyl group Chemical group 0.000 claims abstract description 3
- WGCNASOHLSPBMP-UHFFFAOYSA-N hydroxyacetaldehyde Natural products OCC=O WGCNASOHLSPBMP-UHFFFAOYSA-N 0.000 claims abstract description 3
- 238000002360 preparation method Methods 0.000 claims description 26
- 239000004480 active ingredient Substances 0.000 claims description 12
- -1 alkylene ester Chemical class 0.000 claims description 9
- 125000005456 glyceride group Chemical group 0.000 claims description 7
- 229920006395 saturated elastomer Polymers 0.000 claims description 7
- 239000000126 substance Substances 0.000 claims description 7
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims description 6
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 claims description 6
- 239000000654 additive Substances 0.000 claims description 6
- 229920001223 polyethylene glycol Polymers 0.000 claims description 6
- 229920002535 Polyethylene Glycol 1500 Polymers 0.000 claims description 5
- 239000008172 hydrogenated vegetable oil Substances 0.000 claims description 5
- VUYXVWGKCKTUMF-UHFFFAOYSA-N tetratriacontaethylene glycol monomethyl ether Chemical compound COCCOCCOCCOCCOCCOCCOCCOCCOCCOCCOCCOCCOCCOCCOCCOCCOCCOCCOCCOCCOCCOCCOCCOCCOCCOCCOCCOCCOCCOCCOCCOCCOCCOCCO VUYXVWGKCKTUMF-UHFFFAOYSA-N 0.000 claims description 5
- 239000004359 castor oil Substances 0.000 claims description 3
- 235000019438 castor oil Nutrition 0.000 claims description 3
- 235000014113 dietary fatty acids Nutrition 0.000 claims description 3
- 229930195729 fatty acid Natural products 0.000 claims description 3
- 239000000194 fatty acid Substances 0.000 claims description 3
- 239000007903 gelatin capsule Substances 0.000 claims description 3
- 235000011187 glycerol Nutrition 0.000 claims description 3
- ZEMPKEQAKRGZGQ-XOQCFJPHSA-N glycerol triricinoleate Natural products CCCCCC[C@@H](O)CC=CCCCCCCCC(=O)OC[C@@H](COC(=O)CCCCCCCC=CC[C@@H](O)CCCCCC)OC(=O)CCCCCCCC=CC[C@H](O)CCCCCC ZEMPKEQAKRGZGQ-XOQCFJPHSA-N 0.000 claims description 3
- 239000000314 lubricant Substances 0.000 claims description 3
- 239000003981 vehicle Substances 0.000 claims description 3
- 235000019482 Palm oil Nutrition 0.000 claims description 2
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims description 2
- 229930006000 Sucrose Natural products 0.000 claims description 2
- 239000011230 binding agent Substances 0.000 claims description 2
- XXJWXESWEXIICW-UHFFFAOYSA-N diethylene glycol monoethyl ether Chemical compound CCOCCOCCO XXJWXESWEXIICW-UHFFFAOYSA-N 0.000 claims description 2
- 150000004665 fatty acids Chemical class 0.000 claims description 2
- 239000002540 palm oil Substances 0.000 claims description 2
- 239000003755 preservative agent Substances 0.000 claims description 2
- 239000005720 sucrose Substances 0.000 claims description 2
- 239000002562 thickening agent Substances 0.000 claims description 2
- 239000000796 flavoring agent Substances 0.000 claims 1
- 239000003346 palm kernel oil Substances 0.000 claims 1
- 235000019865 palm kernel oil Nutrition 0.000 claims 1
- 239000003381 stabilizer Substances 0.000 claims 1
- 239000013543 active substance Substances 0.000 abstract description 10
- 150000003077 polyols Chemical class 0.000 abstract description 2
- 150000002009 diols Chemical class 0.000 abstract 1
- 239000008194 pharmaceutical composition Substances 0.000 abstract 1
- 229920000728 polyester Polymers 0.000 abstract 1
- 108010036941 Cyclosporins Proteins 0.000 description 7
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 5
- 239000007788 liquid Substances 0.000 description 5
- 239000008280 blood Substances 0.000 description 4
- 210000004369 blood Anatomy 0.000 description 4
- 241000282472 Canis lupus familiaris Species 0.000 description 3
- 208000027866 inflammatory disease Diseases 0.000 description 3
- 238000000034 method Methods 0.000 description 3
- 239000003921 oil Substances 0.000 description 3
- 235000019198 oils Nutrition 0.000 description 3
- 239000007787 solid Substances 0.000 description 3
- 241001465754 Metazoa Species 0.000 description 2
- 239000002775 capsule Substances 0.000 description 2
- 150000002148 esters Chemical class 0.000 description 2
- 229960003444 immunosuppressant agent Drugs 0.000 description 2
- 239000003018 immunosuppressive agent Substances 0.000 description 2
- 239000000155 melt Substances 0.000 description 2
- 208000023275 Autoimmune disease Diseases 0.000 description 1
- KCXVZYZYPLLWCC-UHFFFAOYSA-N EDTA Chemical compound OC(=O)CN(CC(O)=O)CCN(CC(O)=O)CC(O)=O KCXVZYZYPLLWCC-UHFFFAOYSA-N 0.000 description 1
- 208000010362 Protozoan Infections Diseases 0.000 description 1
- 208000025747 Rheumatic disease Diseases 0.000 description 1
- 230000003110 anti-inflammatory effect Effects 0.000 description 1
- 230000002141 anti-parasite Effects 0.000 description 1
- 239000003096 antiparasitic agent Substances 0.000 description 1
- 229940125687 antiparasitic agent Drugs 0.000 description 1
- 230000002917 arthritic effect Effects 0.000 description 1
- 230000001363 autoimmune Effects 0.000 description 1
- 239000000969 carrier Substances 0.000 description 1
- 235000005687 corn oil Nutrition 0.000 description 1
- 239000002285 corn oil Substances 0.000 description 1
- 230000006866 deterioration Effects 0.000 description 1
- 239000003085 diluting agent Substances 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 238000004090 dissolution Methods 0.000 description 1
- 239000002552 dosage form Substances 0.000 description 1
- 230000035622 drinking Effects 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 150000002170 ethers Chemical class 0.000 description 1
- 239000002360 explosive Substances 0.000 description 1
- 239000000945 filler Substances 0.000 description 1
- 238000002875 fluorescence polarization Methods 0.000 description 1
- 239000008187 granular material Substances 0.000 description 1
- 238000010438 heat treatment Methods 0.000 description 1
- 230000036571 hydration Effects 0.000 description 1
- 238000006703 hydration reaction Methods 0.000 description 1
- 230000007062 hydrolysis Effects 0.000 description 1
- 238000006460 hydrolysis reaction Methods 0.000 description 1
- 230000002209 hydrophobic effect Effects 0.000 description 1
- 238000003018 immunoassay Methods 0.000 description 1
- 230000001976 improved effect Effects 0.000 description 1
- 230000004968 inflammatory condition Effects 0.000 description 1
- 238000011835 investigation Methods 0.000 description 1
- 238000012153 long-term therapy Methods 0.000 description 1
- 201000004792 malaria Diseases 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 238000002844 melting Methods 0.000 description 1
- 230000008018 melting Effects 0.000 description 1
- 230000003589 nefrotoxic effect Effects 0.000 description 1
- 231100000381 nephrotoxic Toxicity 0.000 description 1
- 239000004006 olive oil Substances 0.000 description 1
- 235000008390 olive oil Nutrition 0.000 description 1
- 239000004033 plastic Substances 0.000 description 1
- 108090000765 processed proteins & peptides Proteins 0.000 description 1
- 102000004196 processed proteins & peptides Human genes 0.000 description 1
- 230000002035 prolonged effect Effects 0.000 description 1
- 239000011253 protective coating Substances 0.000 description 1
- 206010039073 rheumatoid arthritis Diseases 0.000 description 1
- 210000003752 saphenous vein Anatomy 0.000 description 1
- 238000012216 screening Methods 0.000 description 1
- 239000008159 sesame oil Substances 0.000 description 1
- 235000011803 sesame oil Nutrition 0.000 description 1
- 239000004094 surface-active agent Substances 0.000 description 1
- 238000005809 transesterification reaction Methods 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
- A61K38/12—Cyclic peptides, e.g. bacitracins; Polymyxins; Gramicidins S, C; Tyrocidins A, B or C
- A61K38/13—Cyclosporins
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4858—Organic compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/02—Immunomodulators
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/02—Immunomodulators
- A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Immunology (AREA)
- Pharmacology & Pharmacy (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Epidemiology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Molecular Biology (AREA)
- Biophysics (AREA)
- Transplantation (AREA)
- Gastroenterology & Hepatology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
- Peptides Or Proteins (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DE4312728 | 1993-04-20 | ||
| DE4412201A DE4412201A1 (de) | 1993-04-20 | 1994-04-08 | Neue pharmazeutische Zubereitungen zur oralen Verabreichung enthaltend Cyclosporin |
| PCT/EP1994/001228 WO1994023733A1 (de) | 1993-04-20 | 1994-04-20 | Neue pharmazeutische zubereitungen zur oralen verabreichung enthaltend cyclosporin |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| NO954152L NO954152L (no) | 1995-10-18 |
| NO954152D0 NO954152D0 (no) | 1995-10-18 |
| NO321076B1 true NO321076B1 (no) | 2006-03-13 |
Family
ID=25925049
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| NO19954152A NO321076B1 (no) | 1993-04-20 | 1995-10-18 | Farmasoytisk preparat for oral administrasjon inneholdende cyklosporin |
Country Status (13)
| Country | Link |
|---|---|
| EP (1) | EP0697881B2 (de) |
| JP (2) | JP3862273B2 (de) |
| AT (1) | ATE218878T1 (de) |
| CA (1) | CA2161143A1 (de) |
| CZ (1) | CZ291237B6 (de) |
| DK (1) | DK0697881T3 (de) |
| ES (1) | ES2178653T3 (de) |
| FI (1) | FI116120B (de) |
| HU (1) | HUT72738A (de) |
| NO (1) | NO321076B1 (de) |
| PT (1) | PT697881E (de) |
| SK (1) | SK283442B6 (de) |
| WO (1) | WO1994023733A1 (de) |
Families Citing this family (15)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5827822A (en) * | 1996-03-25 | 1998-10-27 | Sangstat Medical Corporation | Cyclosporin a formulations as nanoparticles |
| US5834017A (en) * | 1995-08-25 | 1998-11-10 | Sangstat Medical Corporation | Oral cyclopsporin formulations |
| US5962019A (en) * | 1995-08-25 | 1999-10-05 | Sangstat Medical Corporation | Oral cyclosporin formulations |
| US5766629A (en) * | 1995-08-25 | 1998-06-16 | Sangstat Medical Corporation | Oral cyclosporin formulations |
| DE19545043A1 (de) * | 1995-12-02 | 1997-06-05 | Scherer Gmbh R P | Pharmazeutische Präparate zur oralen Anwendung und Verfahren zu ihrer Herstellung |
| SG115386A1 (en) * | 1997-01-30 | 2005-10-28 | Novartis Ag | Hard gelatine capsules containing pharmaceutical compositions substantially free of any oil |
| DE69828496T2 (de) * | 1997-03-12 | 2006-03-23 | Abbott Laboratories, Abbott Park | Hydrophile binäre systeme zur verabreichung von cyclosporin |
| US6008191A (en) * | 1997-09-08 | 1999-12-28 | Panacea Biotec Limited | Pharmaceutical compositions containing cyclosporin |
| US6187747B1 (en) | 1997-09-08 | 2001-02-13 | Panacea Biotech Limited | Pharmaceutical composition comprising cyclosporin |
| US6346511B1 (en) | 1997-09-08 | 2002-02-12 | Panacea Biotec Limited | Pharmaceutical composition comprising cyclosporin |
| EP1039893B1 (de) | 1997-12-10 | 2011-02-02 | Cyclosporine Therapeutics Limited | Omega-3 fettsäure enthaltende pharmazeutische zusammensetzungen |
| US6207179B1 (en) * | 2000-05-18 | 2001-03-27 | Phoenix Scientific, Inc. | Parasiticidal formulation for animals and a method of making this formulation |
| DK1436321T3 (da) | 2001-10-19 | 2006-11-13 | Isotechnika Inc | Syntese af cyclosporinanaloger |
| US6979672B2 (en) | 2002-12-20 | 2005-12-27 | Polichem, S.A. | Cyclosporin-based pharmaceutical compositions |
| US7682433B2 (en) | 2007-05-11 | 2010-03-23 | Canon Kabushiki Kaisha | Ink set, ink jet recording method, ink cartridge, recording unit, and ink jet recording apparatus |
Family Cites Families (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CH641356A5 (en) * | 1979-02-27 | 1984-02-29 | Sandoz Ag | Pharmaceutical compositions containing cyclosporin |
| GB8903804D0 (en) † | 1989-02-20 | 1989-04-05 | Sandoz Ltd | Improvements in or relating to organic compounds |
| DE3580717D1 (de) * | 1984-08-02 | 1991-01-10 | Sandoz Ag | Pharmazeutische anwendung von (nva)2-cyclosporine. |
| ES2033086T3 (es) † | 1988-01-29 | 1993-03-01 | Sankyo Company Limited | Un procedimiento para la preparacion de una composicion farmaceutica. |
| KR0148748B1 (ko) † | 1988-09-16 | 1998-08-17 | 장 크라메르, 한스 루돌프 하우스 | 사이클로스포린을 함유하는 약학조성물 |
| BE1003009A5 (fr) † | 1989-02-09 | 1991-10-22 | Sandoz Sa | Nouvelles compositions pharmaceutiques a base de cyclosporines. |
-
1994
- 1994-04-20 SK SK1298-95A patent/SK283442B6/sk not_active IP Right Cessation
- 1994-04-20 CA CA002161143A patent/CA2161143A1/en not_active Abandoned
- 1994-04-20 PT PT94915073T patent/PT697881E/pt unknown
- 1994-04-20 ES ES94915073T patent/ES2178653T3/es not_active Expired - Lifetime
- 1994-04-20 WO PCT/EP1994/001228 patent/WO1994023733A1/de active IP Right Grant
- 1994-04-20 DK DK94915073T patent/DK0697881T3/da active
- 1994-04-20 CZ CZ19952729A patent/CZ291237B6/cs not_active IP Right Cessation
- 1994-04-20 JP JP52278294A patent/JP3862273B2/ja not_active Expired - Fee Related
- 1994-04-20 EP EP94915073A patent/EP0697881B2/de not_active Expired - Lifetime
- 1994-04-20 HU HU9503019A patent/HUT72738A/hu unknown
- 1994-04-20 AT AT94915073T patent/ATE218878T1/de not_active IP Right Cessation
-
1995
- 1995-10-18 NO NO19954152A patent/NO321076B1/no not_active IP Right Cessation
- 1995-10-19 FI FI954986A patent/FI116120B/fi active IP Right Grant
-
2006
- 2006-05-10 JP JP2006131593A patent/JP2006206615A/ja active Pending
Also Published As
| Publication number | Publication date |
|---|---|
| HU9503019D0 (en) | 1995-12-28 |
| FI116120B (fi) | 2005-09-30 |
| EP0697881B2 (de) | 2009-05-06 |
| PT697881E (pt) | 2002-10-31 |
| SK283442B6 (sk) | 2003-07-01 |
| FI954986A0 (fi) | 1995-10-19 |
| WO1994023733A1 (de) | 1994-10-27 |
| ATE218878T1 (de) | 2002-06-15 |
| CZ291237B6 (cs) | 2003-01-15 |
| CA2161143A1 (en) | 1994-10-27 |
| FI954986A (fi) | 1995-10-19 |
| EP0697881B1 (de) | 2002-06-12 |
| HUT72738A (en) | 1996-05-28 |
| JP3862273B2 (ja) | 2006-12-27 |
| NO954152L (no) | 1995-10-18 |
| JPH08508984A (ja) | 1996-09-24 |
| JP2006206615A (ja) | 2006-08-10 |
| EP0697881A1 (de) | 1996-02-28 |
| SK129895A3 (en) | 1997-02-05 |
| CZ272995A3 (en) | 1996-02-14 |
| DK0697881T3 (da) | 2002-10-07 |
| NO954152D0 (no) | 1995-10-18 |
| ES2178653T3 (es) | 2003-01-01 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| MM1K | Lapsed by not paying the annual fees |